ePRO

Trialflare's ePRO is an electronic patient- and participant-reported outcomes solution built on bring-your-own-device (BYOD) principles. It is designed for clinical trial sites and research teams that need to collect self-reported data from participants across diverse populations, supporting studies ranging from traditional clinical trials through to Phase IV and real-world evidence (RWE) programmes.

The platform covers the full data collection workflow: scheduling and delivering digital forms, monitoring participant compliance in real time, automating team alerts based on participant responses, and visualising data from multiple sources including wearables. It is built to meet regulatory standards including HIPAA, GDPR, and 21 CFR Part 11.

Participant Experience and Device Support

• Supports data collection across laptops, tablets, smartphones, and smart watches.
• Supports multiple languages to accommodate diverse and geographically dispersed participant populations.
• Rated 95% by users; designed to reduce participant burden and lower dropout rates.
• Automated push reminders prompt participants to complete outstanding tasks.
• Supports two-factor authentication (2FA), user ID, password protection, and remote eConsent.
• Compliant with HIPAA, GDPR, 21 CFR Part 11, and other industry security standards.

Monitoring, Scheduling, and Communications

• Forms, messages, and content can be scheduled automatically and delivered at defined timepoints.
• Data collected through ePRO feeds directly into the eCRF via integration with the Trialflare platform.
• Sites can monitor participant progress in real time and receive instant notifications for missing or overdue data.
• Supports communication with participants via app push notifications, SMS, email, and WhatsApp.
• Communications can be queued in advance for an entire study.
• Forms can be sent by push notification or via unique email and SMS links to verified participants, supporting one-off, ad-hoc, and multiple timepoint delivery.

Automated Workflows and Task Management

• Triggers actions and alerts to the study team based on specific participant responses.
• Supports automated monitoring of self-reported health events and adverse events.
• Auto-assignment functionality keeps relevant personnel informed when responses require attention.
• Queries and tasks can be shared across site teams as needed.
• Kanban-style task boards surface items requiring attention from study team members.
• Notes and attachments can be added to queries for team reference.

Real-World Evidence, Phase IV, and Wearables

• Supports longitudinal data collection from smartphones and wearables for RWE and Phase IV trials.
• Garmin integrations enable automatic incorporation of smartwatch data into the eCRF.
• Additional wearable device integrations are available via webhook and API.
• Covers assessment of unexpected side effects and rare adverse events over extended periods.
• Supports outcomes measurement outside traditional clinical environments.
• A library of validated questionnaires is available, covering areas including sleep, stress, exercise, female and male health, gastrointestinal symptoms, coughs and colds, and specific health indications.
• Free-to-use questionnaires can be added directly; licensed questionnaire integration is available at competitive pricing.

Real-Time Reporting and Data Visualisation

• Data from forms, questionnaires, self-reported adverse events, and wearables can be visualised in real time.
• Trend identification supports participant safety monitoring and can accelerate interim analyses.
• Physiological readouts including heart rate, stress levels, and sleep data are available in real time.
• Custom dashboards can be created with a variety of chart types to present data in appropriate formats.
• Data export functionality is included for downstream analysis.

Trialflare ePRO is part of the broader Trialflare platform, which also includes eCRF and eSource products. The solution is positioned for use across clinical and nutritional trials, Phase IV studies, and real-world evidence programmes, with an academic partnership programme also available.